Effects of Auricular Vagus Nerve Stimulation Combined With Slow-paced Breathing on Individuals With Postural Orthostatic Tachycardia Syndrome.

Launched by ALI KAPAN · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for Postural Orthostatic Tachycardia Syndrome (POTS), a condition where people experience a rapid increase in heart rate when they stand up, often leading to dizziness, fatigue, and other troubling symptoms. The study will test whether a combination of auricular vagus nerve stimulation (a gentle electrical stimulation technique) and slow breathing can help improve symptoms better than stimulation alone or a placebo (inactive treatment). The trial will involve 96 participants, who will be divided into three groups to receive different treatments over 12 weeks, all while continuing to monitor their heart rate, mood, and overall quality of life.

To participate, individuals need to have a formal diagnosis of POTS for at least six months and be stable on their medications. They should also be between the ages of 18 and 65 and be willing to provide consent to join the study. Participants can expect to do the treatment daily at home and will have medical assessments before and after the study to track their progress. This trial is based at the Medical University of Vienna and is open to those with POTS, including individuals experiencing lingering symptoms after COVID-19.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Formal diagnosis of Postural Orthostatic Tachycardia Syndrome (POTS), confirmed by clinical criteria: a sustained increase in heart rate (HR) of ≥30 bpm within 10 minutes of standing, without orthostatic hypotension.
• • History of POTS diagnosis for at least 6 months.
• • Participants with Post-acute COVID-19 syndrome may be included if they meet the formal POTS criteria. These participants will be stratified based on the presence or absence of Post-Exertional Malaise (PEM).
• • Stable medication for POTS (same dosage/class) for at least 4 weeks before enrollment.
• • Willingness and ability to provide informed consent.
• Screening of Undiagnosed Participants:
• • Suspected POTS based on clinical symptoms (e.g., dizziness, fatigue, syncope, brain fog, palpitations, exercise intolerance) persisting ≥6 months.
• • Preliminary Schellong test by study team.
• • If criteria are met, referral to a specialist (neurology or cardiology) for diagnostic confirmation.
• • Inclusion only after specialist-confirmed POTS diagnosis.
• Exclusion Criteria:
• • Significant hypertension (BP \>150/100 mmHg supine or standing).
• • Orthostatic hypotension: drop in BP \>20 mmHg systolic or \>10 mmHg diastolic upon standing.
• • Recent stroke or myocardial infarction (within 6 months).
• • Significant immunological or hematological disorders.
• • Severe anemia (hematocrit \<28%).
• • History of vagotomy.
• • Pregnancy or lactation.
• • Inability or unwillingness to provide informed consent.